BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TENSION FREE VAGINAL TAPE

    MDR report key: 3081145 · Received April 26, 2013

    Report

    Report Number
    2210968-2013-04572
    Event Type
    Injury
    Date Received
    April 26, 2013
    Report Date
    April 1, 2013
    Manufacturer
    ETHICON INC
    Product Code
    OTN
    PMA / PMN Number
    K033568
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE PATIENT UNDERWENT MESH IMPLANTATION IN ORDER TO TREAT STRESS URINARY INCONTINENCE. IT WAS REPORTED THAT FOLLOWING INSERTION THE PATIENT EXPERIENCED PAIN, EXTRUSION, INFECTION, URINARY PROBLEMS, RECURRENCE, DYSPAREUNIA, VAGINAL SCARRING AND OTHER.(B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY WITH EXTENSIVE LYSIS OF ADHESIONS, REVISION OF SLING AND EXCISION OF VAGINAL MESH ON (B)(6) 2014 BY DR. (B)(6) DUE TO MESH EXTRUSION, PELVIC PROLAPSE AND HISTORY OF A PELVIC MASS AT THE (B)(6) MEDICAL CENTER, (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON (B)(6) 2006 AND AN OBTURATOR SLING WAS IMPLANTED. THE PATIENT EXPERIENCED PAIN, EROSION OF HER INTERNAL BODILY TISSUE AND OTHER INJURIES FOLLOWING THE PROCEDURE. THE PATIENT HAS UNDERGONE MULTIPLE SURGERIES AND REVISIONARY PROCEDURES. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT DIAGNOSTIC LAPAROSCOPY WITH EXTENSIVE LYSIS OF ADHESIONS, REVISION OF SLING AND EXCISION OF VAGINAL MESH ON (B)(6) 2014 BY DR. (B)(6) DUE TO MESH EXTRUSION, PELVIC PROLAPSE AND HISTORY OF A PELVIC MASS AT THE (B)(6) MEDICAL CENTER, (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182059 TENSION FREE VAGINAL TAPE MESH, SURGICAL, POLYMERIC OTN ETHICON INC NA 1350990

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention